Tamoxifen Versus Etoposide After First Recurrence in GBM Patients

Sponsor
AHS Cancer Control Alberta (Other)
Overall Status
Recruiting
CT.gov ID
NCT04765098
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
58.1
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigator propose a single-center randomized phase II controlled study designed to compare the management of first recurrence of GBM using etoposide versus tamoxifen.

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Controlled Trial of Tamoxifen Versus Etoposide for Patients With First Recurrence of Glioblastoma Multiforme
Actual Study Start Date :
Jan 28, 2022
Anticipated Primary Completion Date :
Aug 1, 2026
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: Etoposide

Drug: Etoposide
etoposide 50mg/m2 daily

Experimental: Tamoxifen

Drug: Tamoxifen
Tamoxifen 20 mg daily for 3 days then 20 mg BID for 3 days then increase by 20 mg daily every 3 days until 100 mg BID continuously

Outcome Measures

Primary Outcome Measures

  1. 3 month progression-free survival [3 months]

    Time between randomization and radiographic or clinical progression leading to change in therapy for recurrent disease or death due to any cause.

Secondary Outcome Measures

  1. One-year progression-free survival [12 months]

    Time between randomization and radiographic or clinical progression leading to change in therapy for recurrent disease or death due to any cause.

  2. Overall survival [Median, 6-month, 1-year, and 2-year OS rates will be measured]

    Time between randomization and death due to any cause. Patients without an event will be censored the last time they were known to be alive.

  3. Health-related quality-of-life status [Throughout study completion, up to 5 years.]

    Health-related quality-of-life will be assessed using the EORTC QLQ-BN20 brain tumor module questionnaire. This is a self-report questionnaire consisting of 20 items that assess future uncertainty, visual disorder, motor dysfunction, and communication deficit in brain tumor patients

  4. Adverse events [Throughout the whole duration of the trial, up to 5 years]

    This includes fatigue, hematologic toxicities (neutropenia, thrombocytopenia, leukopenia, anemia), liver toxicities, hypertension, diarrhea, seizures and thrombosis and will all be recorded.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Histologically proven GBM with progression after previous first line chemoradiotherapy with temozolomide.

  2. Progression documented by MRI with at least one bi-dimensionally measurable target lesion with one diameter of at least 10 mm, visible on two or more axial slices 5 mm apart.

  3. Not received radiotherapy within the three months before the diagnosis of progression.

  4. Stable or decreasing dose of corticosteroids prior to randomization: corticosteroids (dexamethasone) should be given at the lowest dose needed to control symptoms arising from increased intracerebral edema.

  5. ECOG performance 0-2 (Appendix 2).

  6. Age from 18-65 years.

  7. Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 72 hours prior to the first dose of study treatment. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes.

  8. Patients of childbearing / reproductive potential should use adequate birth control methods, as defined by the investigator, during the study treatment period and for a period of 60 days after the last dose of study drug. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.

Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard.

  1. Laboratory evaluation obtained within 7 days prior to randomization, with adequate function as defined below:
  • ANC ≥ 1.5 x 109/L

  • Platelets ≥ 100 x 109/L

  • Serum creatinine ≤ 1.5 times ULN

  • Total serum bilirubin ≤ 1.5 times ULN

  • ALT < 3 times ULN

  • AST < 3 times ULN

  • Alkaline phosphatase < 3 times ULN

  1. Patient must understand and sign an informed consent prior to study registration.
Exclusion Criteria:
  1. History of another malignancy or a concurrent malignancy (exceptions include patients who have been disease-free for 3 years, or patients with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible, for example cervical cancer in situ.

  2. Uncontrolled hypertension (systolic blood pressure >150 mm Hg or diastolic blood pressure >100 mm Hg).

  3. Any arterial or venous thrombosis up to 6 months before registration.

  4. Evidence of recent hemorrhage on brain MRI.

  5. Substantial cardiovascular disease: cerebral vascular accident/stroke (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (> New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Cross Cancer InstituteEdmontonAlbertaCanada

Sponsors and Collaborators

  • AHS Cancer Control Alberta

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT04765098
Other Study ID Numbers:
  • IIT-0014
First Posted:
Feb 21, 2021
Last Update Posted:
Apr 6, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2022